HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone cream 
Actavis Pharma, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Hydrocortisone Cream Maximum Strength - Actavis

Drug Facts


Active ingredient

Hydrocortisone, USP 1%

Purpose

Anti-itch

Uses

for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

•eczema      •insect bites      •poison ivy      •poison oak      •poison sumac      •soaps

•jewelry      •detergents       •cosmetics       •psoriasis          •seborrheic dermatitis

•for external genital, feminine and anal itching

•other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only

Do not use

  • for external feminine itching if you have a vaginal discharge. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor.

When using this product

•avoid contact with the eyes   •do not begin the use of any other hydrocortisone product unless directed by a doctor

•for external anal itching:   •do not use more than directed unless directed by a doctor   

•do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

•symptoms last for more than 7 days   •the condition gets worse   •symptoms clear up and occur again in a few days   •rectal bleeding occurs, consult doctor promptly

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older  •apply to affected area not more than 3 to 4 times daily
Children under 2 years of age   •do not use, consult a doctor 
For external anal itching
Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet issue or a soft cloth before application of this product
Children under 12 years of age: consult a doctor

Other information

  • Store at room temperature 59°-86°F (15°-30°C).  Protect from freezing.
  • Before using any medication, read all label directions.  Keep carton, it contains important information.

Inactive ingredients

cetyl alcohol, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax.  May contain citric acid or sodium citrate solution to adjust pH.

Questions?  

1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.

PRINCIPAL DISPLAY PANEL

Actavis

NDC 0472-0343-56
Compare to the active ingredient in Cortaid® Maximum Strength Cream*
Maximum Strength
Hydrocortisone Cream, USP 1%
Anti-itch Cream
Relieves Itches and Rashes
 

Relieves itches and rashes due to:
•Poison Ivy, Oak, Sumac  •Insect Bites
•Eczema      •Psoriasis      •Seborrheic Dermatitis 

Net wt. 1 oz (28g)

Hydrocortisone Cream
HYDROCORTISONE  MAXIMUM STRENGTH
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0472-0343
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SORBIC ACID (UNII: X045WJ989B)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
WHITE WAX (UNII: 7G1J5DA97F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0472-0343-561 in 1 CARTON07/01/199711/30/2022
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/01/199711/30/2022
Labeler - Actavis Pharma, Inc. (119723554)

Revised: 9/2022
 
Actavis Pharma, Inc.